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Sterility Testing by Direct Inoculation Method

Sterility Testing by Direct Inoculation Method Direct Inoculation Method Learn the procedure for sterility test for sterile pharmaceutical products by direct inoculation method. 1.0 Objective :  To lay down Standard Operating Procedure is to provide guidelines for sterility testing by Direct Inoculation Method. 2.0 Scope This procedure is applicable for the products manufactured at the location which can not be tested by Membrane Filtration Method. 3.0 Responsibility Implementation: Microbiologist 4.0 Accountability Execution: Manager - QC Review & Approval : AGM - QA / QC Procedure Direct Inoculation Method Sample for Finished Products: Collect the samples to be tested for sterility. Out of the whole sample, randomly select 20 articles of each lot of batch for both LVP and SVP t erminal ly sterilized products and for aseptically filled products.    Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bot...
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SOP for Washing of HPLC Column After Use

SOP for Washing of HPLC Column After Use Standard operating procedure to wash the HPLC column after analysis. 1.0 OBJECTIVE To clean the column thoroughly after its each use to avoid any interference on repeated usage. 2.0 SCOPE This procedure is applicable for different groups of H.P.L.C columns used in Quality Control laboratory. 3.0 RESPONSIBILITY 2.1 Doing: Technical Assistant 2.2 Checking: Executive /Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 For C18, C8, C6, Phenyl, (CN, Amine, Silica column.:) 5.1.1 Wash the column with the solvent which is use in individual product mobile phase preparation. eg. suppose water is use in mobile phase  preparation then wash the column with water. 5.1.2 Allow the minimum 30 ml washing medium to flow through the column. 5.1.3 Disconnect the column from the HPLC unit and store in an allocated place. 5.2 For Protein pack column: 5.2.1 Wash the column with minimum 30 ml of 2.5 M acetic acid. 5.2.4 Disconnect the column from ...
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Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture  sterile pharmaceutical products   as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the  FFS   and BFS is to reduce the  contamination   by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of  sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...
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High-Efficiency Particulate Air (HEPA) and Its Significance in Sterile Pharmaceutical Preparations

High-Efficiency Particulate Air (HEPA) and Its Significance in Sterile Pharmaceutical Preparations Everything about HEPA filters as pore size, leak test, DOP test and importance in sterile pharmaceutical manufacturing and analysis. HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or through various points on the filter media. Thereafter, leak tests should be performed at suitable time intervals for HEPA filters in the aseptic processing facility. For example, such testing should be performed twice a year in the aseptic processing room. Additional testing may be appropriate when air quality is found to be unacceptable, facility renovations might be the cause of disturbances to ceiling or wall structures, or as part of an investigation into a media fill or drug product sterility failure. Among the filters that should be leak tested ar...
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Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...
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